A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

Completed · Phase 2 · Has a placebo group

Conditions studied: Overweight, Obesity

In brief

This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.

Key facts

Study ID

NCT00402077

Run by

AstraZeneca

People needed

258

Starts

2006-11-01

Expected to finish

2007-08-01

Last updated by the study team

2015-03-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is obese with a Body Mass Index (BMI) >=30 kg/m\^2 to <=50 kg/m\^2 or overweight with a BMI >=27 kg/m\^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions)
• Has been obese or overweight for at least one year prior to study start
• Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: *hormone replacement therapy; *oral contraceptives; *lipid-lowering agents; *thyroid replacement therapy; *metformin

You may not qualify if…

• Is currently enrolled in or is planning to enroll in a formal weight-loss program
• Is unwilling or unable to participate in a lifestyle intervention program as part of the study
• Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: *prescription or over the counter antiobesity agents (within the 6 months prior to study start); *psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); *steroids that are known to result in high systemic absorption; *calcitonin; *ketoconazole; *antidiabetic medications
• Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study
• Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start
• Has previously used pramlintide either by prescription or as part of a clinical study
• Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start
• Has donated blood within 2 months before study start, or is planning to donate blood during the study

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Chula Vista, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Miami, Florida, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — New York, New York, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Statesville, North Carolina, United States
• Research Site — Eugene, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Austin, Texas, United States
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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